Video: Go In For Migraine, End Up With Amputation

By Ben PopkenNovember 21, 2008

Imagine going to the doctor for a severe migraine and ending up with your right arm amputated. That’s what happened to Diana Levine when her doctor injected her with Phenergan, it seeped out of the vein into an artery, and gave her gangrene.

Vermont courts found that Wyeth hadn’t given adequate warning to doctors and patients that one particular injection method, the one used on Diana, greatly increases the risk of gangrene. Wyeth is trying to use Federal preemption to win the case, arguing that patients is that consumers can’t sue a pharma company if the drug has been approved by federal regulators. The case, Wyeth v. Levine, is before the Supreme Court. The Alliance for Justice has made a 22-minute documentary about Diana Levine so you can learn more about her story. Watch it in its entirety, inside…

I started reading this as I took my daily Phenergan pill. I realize that the problem is with a bad injection and not the pill, but for a moment it was fairly difficult to swallow. (And that pill tastes nasty.)

@Oranges w/ Cheese: I have something that works, and it can’t cause what we see here. It doesn’t seem like a good idea to give up something that works to try other things that might not work or that might have far worse side effects.

If she took a pill and had this happen, I’d be on the phone right now. But dumping the pills would be like refusing to drink water because people drown in it.

@nsv: And that pill tastes nasty.Great news…IT’S A SUPPOSITORY! Actually it does come in a suppository and works extremely fast. Not that I have much experience with inserting foreign objects in my money maker.

@mgy: He lives in the town next to Diane. I grew up in the same town, her daughter is friends with my little brother, and I spent a good amount of time with Diane when I was younger. This is a sad story and I hope some good can come of it. It’s a tricky situation here with the label policies, but the pharma companies are basically saying that once the label is approved they shouldn’t need to be changed. I don’t think that should be the case…clinical trials can only cover so much.

I hate to side with a pharma company, but I’m not really sure it’s anyone’s fault in this case. It certainly sucks big time, and she should be compensated somehow. But I wouldn’t make Wyeth out to be a villain in this case.

This documentary made me more angry at the woman than the company or doctor.

@tc4b: Medicine isn’t like mathematics. There’s always a risk. If you ask doctors to be responsible for the risk, then they will charge everybody more.

That’s how social insurance works. Either shit happens on occasion and you deal with it or everybody goes poor giving money to everybody else because shit happens.

So, that said… if she knew about this complication and didn’t tell her doctor… it’s not her doctor’s fault. If she didn’t know about this then that just sucks and I feel bad for her, but I don’t think it’s the doctor’s fault. It could be the pharma’s fault, but it’d have to be shown that a great enough percentage of people who get this injected have complications to warrant putting a warning label on there. And even then it’s just a “hey, know the risk!” type of thing and not a ticket to free monies.

It’s more like saying that that the beef suppliers for McDonalds knew that a very, very small part of their beef product was tainted with disease x, but didn’t properly inform McDonalds of this because it was almost negligible. Woman contracts disease x, though. Then sues.

@friedduck:
I said that she should be compensated. It’s obviously not her fault. But the documentary goes a little too far to make us feel worse of a situation that is already pretty bad. It just didn’t seem necessary to me.

Extremely troubling, and not only becuase of Diana’s tragedy (she also can’t work now, since she’s a guitar player/musician). I can’t watch the video at work, but I’ve been following for a while, and – if I understand it correctly – a ruling in Wyeth’s favor could have huge ramifications for consumers & producers of anything federally regulated or registered. If you’re injured by something the fed has officially ‘signed off’ on, you wouldn’t be able to demand compensation from the company, since they submitted whatever it was to the govt and it becomes whichever agency’s responsibility.

I’m not sure if in that case the govt agency would be liable…. it seems like it would make consumer protection a lot more complicated. And worse. It seems that lawsuits are more effective and costly than regulations and fines.

@oneandone: consumer protection will be “a lot more complicated” if Diana wins. If she wins, that means that when a drug company is putting warnings on their drugs, they can’t just use the warning that the federal government has approved. They have to figure out what the courts in each state think a good warning would be. Do they design different packaging for each of the 50 states? Do they combine all the different warnings and distribute a paperback book with each bottle of medicine? And every time a consumer sues, and wins, they have to update the warning again to match what the court in the latest case thought the warning should have been.

Your medication is going to be a lot more expensive if this woman wins.

@vespolina: Wrong. They’d most likely figure out the requirements ofthe states that require the most stringent guidelines and apply them to other states. The WHOLE idea of warning labels is laughable anyway, since manufacturers submit their own labels for approval, the feds can only really suggest warnings…

Yeah, also considering that a lot of people don’t even get exposed to the warning labels. Docs very rarely get informed consent before giving drugs because the docs themselves haven’t read the package inserts.

@vespolina: I agree, either way it ends up more complicated – but if Wyeth wins, I think it results in less consumer proection, assuming that federal inspections, enforcement, and regulation continue to be what they’ve been. I’d much rather have a paperback book outlining the risks of every medication than have no recourse after being injured by something that at some point passed through federal regulatory channels and thus required no corporate responsibility.

The paperback book would be ridiculous, but imo it’s the preferable outcome. The ideal outcome would be if this had never gotten to the court, because there’s no way it can end well.

What happened to her no doubt is horrific, but it is completely unrealistic to expect that every patient is informed of every known side effect of a drug before being administered one. It never fails to amaze me when people are surprised that drugs have side effects, sometimes nasty ones. And you know, promethazine IVPush is probably given 10s of millions of times in hospitals with almost no serious adverse effects.

Also, the intro is not correct – the drug did not “[seep] out of the vein into an artery.” Whoever got IV access on her initial cannulated a damn artery. If they had cannulated a vein like they were supposed to, this never would have happened. Blaming the drug for causing a problem when the drug was clearly used incorrectly is a bit bothersome. That’s like saying my blender chewed my fingers off when I stuck my hand inside it while it was running. The hospital/nurse/etc are primarily responisble for this error, not the drug company.

This marks the first time in my professional career that I’m defending the drug companies!

@dougp26364: @larsitron: Actually the doctor/clinic/insurance company associated with wherever the thing was done, already settled out of court. She’s taking on the Pharm company because the warning label that the doctor didn’t read anyways didn’t say…”BTW if you fuck up with the iv push your arm will fall off”

The drug company knew that this was an issue with this specific method of delivery and did not notify providers of the warning. Had the patient been told there may be a risk of losing her arm, I doubt she would have ever accepted the drug. Whether the nurse did not do the proper set up or not is irrelevant, since the nurse did not know the possible complications as well.

@rellog: No patient is ever going to be told something like that in a way that they will be discouraged treatment. At best they would get a piece of paper with the risks. Doctors are not going to tell people of the worst possible obscure side effect as if it’s guaranteed to happen, no one would take medication.

I’ve heard that the FDA is markedly easier to get stuff thru, due to changes to make things more industry friendly and “efficient”. I wonder how these changes over the past 8 years have impacted risky drugs getting to market, and if perverting the FDA’s mission in such a fashion means there’s more responsibility for the drug manufacturer than in the past.

My thinking’s the same as MBPharmD on this one. As much as I distrust big pharmaceuticals who mark up the drugs ridiculously, and the bad companies who often will push a dangerous drug on the market before approval, it’s not Wyeth’s fault here. There’s even a company in this video that is blamed for bad labels, big time their fault. But here it seems that they’re somehow trying to pin the blame on the drug company.

The effect was known. Gangrene = amputation. Her doctor acknowledged that he knew about the effect. If she had any other drug or even saline, it could also ‘seep out’ (which seems more like a bad excuse) if given improperly. It sounds like it wasn’t properly checked that it had been administered to the vein.

There’s no surprise she’s after the drug company though. She wants one thing now: money. Compensation. Can’t say I blame her, I’d be pissed if I lost an arm, but her doctor doesn’t look like he’s rolling in dough, so her lawyer likely suggested they go after someone with cash.

“I’ve heard that the FDA is markedly easier to get stuff thru, due to changes to make things more industry friendly and “efficient”.”
As someone who works in this industry, I assure you that you have no idea what you are talking about. There is nothing “easy” about drug approval at the FDA. Period.

It comes with the drug’s territory; I’ve given IV Phenergan hundreds of times with absolutely no adverse side effects other than a little tingling in the veins. It isn’t the only drug in the world that can be caustic to veins, so are we going to go on to ban all drugs that are? IV Dextrose, basically sugar water, that is used in emergency situations for low blood sugar, is the same way, do we ban that too?

This has NOTHING to do with the drug and everything to do with the fact that the nurse thought she was hitting a vein and instead hit an artery. Veins go back to your heart to be absorbed, whereas an artery in your arm would go to your fingertips, then back up to the vein and heart. Any moron that’s started an IV should be able to instantly tell that they’re inside a vein instead of an artery, and if they can’t then they deserve to be sued.

Bottom line: If you’re a sue happy prick, at least sue the right people.

@Tightlines: Yeah, what the fuck is she complaining about? “Ooh, I lost an aarrrrmmmm.” Big deal. You got another one, get over. I’m with you, comrade rtmccormick! If we don’t speak the truth, who will?

@rtmccormick: This is ridiculous that you’d refer to the plantiff as “sue happy.” The patient was never advised of a documented risk that the drug company knew about. And the fact that there are other more safe methods to use this drug means there is no reason to use this specific method and risk the complications associated with it.

@rellog:
There are “documented risks” for every drug in the world. There is no risk-free drug; you can have an allergic reaction to other inactive ingredients in Benadryl, which is used to combat allergic reactions.. Should a drug representative from every major pharma company be waiting at every possible end-user point to advise the recipient that.. GASP… something bad might happen when a foreign substance is pumped into your body? That’s what this case is suggesting. It’s not the drug company’s responsibility to make sure the drug is used properly and the risks are explained. It’s the prescriber and ultimately the end user.

The issue in this case was not that the drug itself causes a problem in particular, but rather that the healthcare provider attemped to access a vein in her upper arm and instead hit the artery. This is a twofold problem:

1. Arteries don’t react well to trauma because they’re programmed to clamp down to prevent blood loss.

2. There’s one main artery in that part of the arm, so trauma to it (and the secondary constriction) causes lack of blood further down the limb. This anatomical issue is why most clinical providers don’t routinely attempt to access veins in this region.

The person who should be sued isn’t the drug company but rather the provider who used poor technique to disasterous consequences.

@larsitron: I think that was the issue, but now it’s become a new issue – federal pre-emption, and whether or not federal regulation of a drug (or food, or pesticide, or whatever) waives the manufacturer of liability for injury caused by that drug.

The nurse (and I think the clinic) were sued by this patient and lost, but now it’s morphed into something else, which is unfortunate.

I got an injection of this stuff when I was in college, but they shot it into my glute instead of my arm. The nurse said “it’s pretty caustic, so we use a bigger muscle to avoid damaging a smaller muscle like the ones in your arm and shoulder.”

It fucking BURNED going in, holy crap. I’ve never had a shot hurt like that before. I can see why it could cause major problems if it were injected improperly.

The good news, I guess, is that I finally stopped throwing up, and the nurses at the student clinic gave me juice boxes since it can also cause drymouth.

Regardless of who’s fault it was (*cough* whoever gave her the injection *cough*), how in the world did she lose an arm from gangrene??? She and her doctor had to have both been absolute morons to not catch gangrene in time to save the arm.

That said, sue the doctor, not the maker of the drug that was wrongly administrated.

1) What was the % of gangreen incidents in clinical trials? .1%? 1%? .00001%? 10%? It makes a huuuuge difference how many other people experience in terms of whether its reportable to the patients using them. Just because one person had a bad reaction to it doesn’t mean every single patient needs to be informed. But, if it was a large enough percentage, then yes the doctors and patients should be informed.

2) I’m going to assume the doctor wasn’t sued because it was determined he did nothing wrong. But then again its a little vague and who knows what really happened. Based off this story there is no proof whether the drug is actually dangerous or was just administered wrong.

There’s 3 possible situations here… 1) the doctor/nurse adminstered the drug wrong and should be sued 2) the drug company knowingly concealed a bad sideffect that was statistically significant and should be sued 3) she just got really freaking unlucky and was part of that .01% of people who react badly and she’s out of luck. Not every single case of medical cases gone wrong has proper cause for a lawsuit. Doctor’s and medicine isn’t infallible, sometime crap happens and its not anyones fault. Everyone single procedure, no matter how minor, has potential negative consequences outside the control of the medical staff.

@ilves: It only causes Gangrene when its used incorrectly. Also 2 is wrong, the clinic was sued, they settled out of court.

The problem here is the the clinician incorrectly inserted the IV into an artery instead of a vein. Phenergan has been around since the 60’s, and this is the first suit of this nature. I think that says something.

@ilves: The first reported gangrene incident was I believe seven or eight years after the drug was introduced in the 1950s. I believe the number of reported gangrene incidents is something like 50 in the past 53 years. That’s incredibly low.

The fact remains that this effect is not really a side effect of the drug. It’s a side effect of the administration, which is common to MANY IV administered drugs. The doctor made a choice to administer it, and a mistake was made. Diana Levine has successfully sued, and settled with, the clinic and practitioner who administered the drug.

I listened to the oral arguments and I thought that the plaintiff’s argument was very weak. The FDA label is only a floor and each state can require a different label? That directly conflicts with federal law requiring a drug’s label to be certified by the FDA. You cannot possibly include every eventuality on a drug label, these things run DOZENS of pages.

To award $6 million in damages on the basis that a drug company was negligent by not specifically stating that a drug should NOT be adminstered in a manner it was approved for is dangerous territory indeed.

Frankly, I hope Wyeth wins this one. One of the key ideas of the use of drugs in health care is the weighing of risks and benefits. A patient should not have the right to sue in state court over a drug that is regulated by a federal agency, it puts too much of the responsibility on the company for a drug when the government gets the final word on all the approved uses, etc.

@sonneillon: Yes, damn the law, damn the consequences for society as a whole, lets just ignore actual culpability to make sure this woman is compensated for the loss of her arm due to mistaken application of a drug. Oh wait, she was! She settled out of court with the clinic who’s fault this whole thing actually is.

If we applied your standard on a wider scale, than we might as well just throw the whole concept of rule of law out the window. If you think that a company that is not actually culpable should pay just to make this lady feel better than your an idiot of the highest order.

@Valhawk: Then who do you suggest is culpable. If the doctor messed up then the clinic is, if the drug was faulty then the company that produced the drug is. It’s one or the other. I understand that just because bad things happen doesn’t mean someone is culpable, but this comes from negligence and as I said it’s either the clinic or the drug manufacturer. Pick one.

@sonneillon: The nurse is culpable, just like I said in my comment, she misapplied the drug, that’s why the clinic settled out of court.

This woman has already received compensation from the clinic that actually crippled her by misapplying a drug with a known side effect if misapplied. This is about as cut and dry culpability as you’ll ever find.

Going after Wyeth for a known side effect of a drug that’s been on the market for more than half a century just reeks of aiming for deep pockets.

There are several drugs that will cause necrosis of the tissue if the IV infiltrates, like Nipride. Any doctor or nurse should have flushed the IV prior to administration of the medicine to make sure that the line was still patent. What happened to this woman was a tragedy, but it is not really feasible to list every single side effect of every single drug that you have ever taken/been given.

not quite. It wasn’t intentionally adminstered into an artery (that would be malicious) but instead the nurse who started the IV didn’t verify the IV flow before giving the drug (as is my understanding of the circumstances.) So yes, the information is wrong, but it was given by IV and mistakenly entered an artery.

This is really interesting as a nursing student Phenergan is a common drug. When looking it up no where does it discuss gangrene as a side effect… there is a definite problem with the research and labeling of this drug.

I’m having a hard time imagining how an IV drug (intravenous) “seeps” into an artery! Arteries are not open to seepage, someone must inject them to enter the drug into it. (I’m a registered nurse)Doc nik’d the artery. Or whoever started the IV. They use the term “gangrene” which is basically necrosis of the tissue due to lack of circulation. It happens quite quickly when the arteries clamp down and refuse to administer blood and oxygen to the arm. There’s also nothing you can really do once the process starts. All in all, it’s doc’s fault although I don’t believe the drug companies should be immune to anything. I believe also that the risks of the drug were most likely stated in the insert but not given to the patient before injection. I bet she would have taken it regardless.

An intra-arterial injection may often lead to disaster, as may the “extravasation” or “seeping out of the vein” of several medications. MBPharmD is correct. We weren’t there, but I would bet you dollars to donuts that the needle used for injection wasn’t in a vein “I.V.” at all but intra-arterial (in the artery). Sometimes there’s an alternative or redundant supply of fresh blood (aka “collateral circulation”) and sometimes there’s not. It takes only a few minutes for the artery to shut down (vasospasm) and shut off the blood, and thus the nutrient and oxygen supply, to the parts of the extremity supplied to the artery so affected. Tissue death ensues, and only extremely good management — and in reality, a huge piece of luck — will preserve an extremity injured in this manner. The very survival of the limb is statistically improbable, and its functionally intact survival is well-nigh impossible.

If the FDA would actually do its intended job of protecting the consumer instead of protecting the pharmaceutical manufacturers, and the manufacturers didn’t have a strong if not total control of the FDA, then perhaps pre-emption might work, but as it stands now, there is no way in hell we can put not only our trust, but our lives in the hands of one of the most corrupted organizations of government instead of the justice system is ridiculous to ask of us.

@LeilaniMalicity: Your right, lets rage against the FDA for not protecting us against the misapplication of drugs. If you take 30 Tylenol capsules, its clearly the FDA’s fault for letting the drug go to market. (Sarcasm)

I’m really sorry that this lady was hurt so bad, but promethazine (Phenergan) is a really necessary drug!

Oral promethazine is available over-the-counter in the European Union as a sleep aid. It is one of the best and safest anti-nausea drugs available. It also cures migranes, general pain, and anxiety. My physician girlfriend calls it a dose of STFU, because it cures so many real problems and so many imagined ones too.

Dosing the victim with phenergan in an artery is medical negligence on the part of her health provider, not the manufacturer. She’s suing the wrong person. Many drugs are dangerous if given inappropriately. I’m a healthy person, so insulin could kill me. If I were given digitalis, it could stop my heart, not help it.

The real danger in this lawsuit is that good, working medicine may become unavailable to the people who need it because some other people have administered it inappropriately.